Technical Information - Bayer HealthCare Ascensia Contour Blood Glucose Meter User Manual

Technical Information:

Accuracy
The accuracy of the Ascensia C
ing System has been assessed in a correlation study conducted
by healthcare professionals. In this study, 108 fresh capillary
blood specimens were tested with the Ascensia C
Glucose Monitoring System by 108 untrained people with dia-
betes using three test strip lots. The reference measurement
was done on the YSI Glucose Analyzer. Ascensia C
compare well with the results from the YSI method.
Regression Statistics (Plasma/Serum Reference):
plasma reference glucose range: 4.2 to 22.0 mmol/L
Lot
1
2
3
Precision
A study was conducted with the Ascensia C
Glucose Monitoring System with fi ve heparinized whole
blood specimens with glucose levels from 2.2 to 18.0
mmol/L. Multiple replicates (n=100) were tested using mul-
tiple Ascensia C
of Ascensia M
lowing precision results were obtained:
Plasma/Serum:
Mean
2.1 mmol/L
5.6 mmol/L
6.5 mmol/L
11.4 mmol/L
18.1 mmol/L
ONTOUR
y =
1.02x – 0.01 mmol/L
1.03x – 0.24 mmol/L
0.95x – 0.02 mmol/L
Blood Glucose Meters and one lot
ONTOUR
Blood Glucose Test Strips. The fol-
ICROFILL
www.ascensia.co.uk
Blood Glucose Monitor-
SD
0.10 mmol/L
0.28 mmol/L
0.24 mmol/L
0.38 mmol/L
0.65 mmol/L
Blood
ONTOUR
data
ONTOUR
Correlation
Coeffi cient
(r)
0.972
0.963
0.974
Blood
ONTOUR
Coeffi cient
of
variation
4.8%
5.1%
3.7%
3.3%
3.6%
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